Job Title:
MDR Vigilance Specialist II
Location:
Nanakramguda, Hyderabad, India
Job Type:
Full-time
Preferred Salary/Compensation:
Competitive Salary (Specific range not disclosed)
Work Mode:
On-site
Job Summary:
Medtronic, a global leader in healthcare technology, invites applications for the position of MDR Vigilance Specialist II at its Hyderabad location. This role is instrumental in managing the medical device surveillance program to ensure strict compliance with global regulatory standards. The position requires collaboration with cross-functional teams to process adverse event data and contribute to product safety and quality assurance, making it ideal for candidates with pharmacovigilance or medical device vigilance expertise.
Key Responsibilities:
Monitor and manage the company’s medical device surveillance program, including intake, evaluation, and follow-up on adverse event reports.
Develop and maintain protocols to ensure regulatory compliance with government agencies.
Accurately maintain and report Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data.
Review, analyze, and integrate data from clinical databases to ensure standardized and quality safety summaries.
Act as a liaison with internal teams and external partners to streamline regulatory reporting processes.
Deliver and oversee assigned projects independently while adhering to company policies and procedures.
Communicate project status, challenges, and updates to stakeholders.
Mentor and guide entry-level professionals when required.
Required Skills & Qualifications:
Bachelor’s degree in a relevant field (as per 8 C.F.R. § 214.2(h)(4)(iii)(A)) with a minimum of 2 years of relevant experience, or an advanced degree with no required experience.
Practical knowledge in pharmacovigilance, medical device vigilance, or regulatory affairs.
Understanding of Medical Device Reporting (MDR) and ADE processes.
Strong analytical skills for data review and integration.
Proficiency in handling regulatory reports and summaries.
Excellent communication skills for cross-functional collaboration.
Ability to manage moderately complex projects with minimal supervision.
Perks & Benefits:
Competitive Salary Package
Flexible Benefits Program
Private Pension Plan and Transport Allowance
Comprehensive Medical and Dental Insurance
Life Insurance Coverage
Gympass Membership Access
Pharmacy Discounts and Childcare Assistance
Employee Stock Purchase Plan (ESPP)
Language and Education Subsidies
Paid Family Leave Policies
Holiday Break Program and Early Closure on Fridays
Company Description:
Medtronic is a global healthcare technology pioneer committed to developing solutions that improve patient outcomes, alleviate pain, and extend life. With over 95,000 employees worldwide, Medtronic remains at the forefront of healthcare innovation, blending advanced engineering with a passion for making a difference.
Call to Action:
Ready to drive regulatory excellence and make an impact in the medical device industry? Apply now to join Medtronic’s team in Hyderabad and shape the future of healthcare safety and compliance.
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